Glioblastoma
Conditions
Interventions
Treatment group:The first cycle of bevacizumab at a dose of 5mg per kilogram of body weight was administered within 2 weeks after randomization, followed by the second cycle at an interval of 2 weeks.
Control group:The first cycle of bevacizumab at a dose of 5mg per kilogram of body weight was administered within 2 weeks after randomization, followed by the second cycle at an interval of 2 weeks. A
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old; 2. KPS>=60 within 2 weeks before treatment; 3. Initially treated tumor has been completely resected or subtotally resected, and there is a clear pathological diagnosis; 4. Patients with glioblastoma recurrence after postoperative standard radiotherapy and chemotherapy treatment; 5. The end of the first course of radiotherapy >=6 months; 6. Expected survival >=3 months; 7. The main organs are functioning well, and the examination indicators meet the following requirements: 7.1 Routine blood examination: Hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count >=1.5×10^9/L; Platelet count >=80×10^9/L; 7.2 Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula); 8. Signed informed consent; 9. Good compliance, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. patients with other malignant tumors at the same time, except those with cured or stable malignant tumors; 2. The primary lesion located in the thalamus or brain stem, or the maximum diameter of the postoperative residual lesion was more than 2cm; 3. There was evidence of spinal cord dissemination by spinal MR Or cerebrospinal fluid examination; 4. Received other glioma related treatments except surgery, chemoradiotherapy, and electric field therapy at the time of initial treatment; 5. patients who underwent reoperation before the second radiotherapy, except for biopsy; 6. Pregnant or lactating women; 7. Participated in other clinical trials within one month; 8. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 9. Any bleeding event of CTCAE 5.0 grade 3 or higher within 4 weeks before screening; 10. Patients with hypertension that is not well controlled by single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: male >=450 ms) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) class >=II cardiac dysfunction; 11. Long-term unhealed wounds or incompletely healed fractures; 12. Previous history of organ transplantation; 13. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during the treatment and causing fatal hemorrhage; 14. Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (INR within the normal range without anticoagulants must be met within 14 days before randomization); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (1 mg orally once daily) or low-dose aspirin (at a dose of up to 100 mg daily) were allowed for preventive purposes if the international normalized ratio (INR) of prothrombin time was 1.5 or less. 15. Previous arterial/venous thrombosis events within one year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization due to previous chemotherapy and judged by investigators to be cured), and pulmonary embolism; 16. Have a history of psychotropic drug abuse and cannot quit or have mental disorders; 17. A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 18. Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or prevent the patient from completing the study; 19. Patients who did not meet the inclusion criteria or who were deemed by the investigator to be unsuitable for trial entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Objective Response Rate (ORR);Quality of Life (QoL);Cognitive Function Score;Adverse Reaction; | — |
Countries
China
Contacts
Public ContactZhirui Zhou
Huashan Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed